AVVA

Dosage form: gel
Ingredients: BENZALKONIUM CHLORIDE 100mg in 100mL
Labeler: AVVA International LLC
NDC Code: 42891-4148

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients                           
Benzalkonium Chloride  0.1%    

Purpose
Antimicrobial

Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away

Uses:  for vaginal cleansing. Kills germs.

Directions:
·   
take of any plastic around the tube
·    remove the small plastic cap from the top of the applicator
·    gently insert the end with small hole of the applicator deep into the vagina,   while in this position gently push the plunger of the applicator to release the  gel
·    remove the applicator and discard it in a waste container
·    children under 12 years of age: Ask a doctor


Do not use if the package seal is broken

Warnings:
For external use only
Do not use
·    more often than twice weekly unless directed by physician
·    to prevent pregnancy
·    during pregnancy
·    if you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)
·    to prevent STD or PID

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if rash, irritation, swelling, pain or redness develops

Do not use more often than twice weekly unless directed by physician

Inactive Ingredients:
allantoin, carbomer, glycerin, hydroxyethylcellulose, sodium hydroxide, water

AVVA 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42891-4148
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
CARBOMER 934 
GLYCERIN 
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:42891-4148-06 TUBE (TUBE) in 1 BOX
1NDC:42891-4148-15.5 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/28/2012
Labeler - AVVA International LLC (020023853)
Establishment
NameAddressID/FEIOperations
AVVA International LLC020023853label

Revised: 06/2012
 
AVVA International LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)